(45 days)
No
The summary describes a standard suction pump and does not mention any AI or ML capabilities.
No.
The device is a suction pump intended for aspiration and removal of surgical fluids, tissue, gases, and bodily fluids, specifically for chest drains in situations like pneumothorax or after surgery. While it assists in medical procedures, it does not directly treat a disease or condition; rather, it removes substances from the body.
No
The device, a suction pump, is used for aspiration and removal of fluids and materials, and for thoracic drainage. Its stated purpose is treatment-oriented (fluid removal, drainage management), not for identifying or diagnosing a condition.
No
The device description explicitly states "Powered Suction Pump," indicating a hardware component. The intended use also describes a physical pump for aspiration and removal of fluids.
Based on the provided information, the Medela® THOPAZ Suction Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- The intended use of the Medela® THOPAZ Suction Pump is for the aspiration and removal of fluids, tissue, gases, and materials directly from the patient's body (specifically the pleural and mediastinal cavity). This is an in vivo (within the living body) procedure, not an in vitro (in glass/outside the body) diagnostic test.
The device is a powered suction pump used for therapeutic and procedural purposes, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Medela® THOPAZ Suction Pump is intended to be used for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. The Medela® THOPAZ Suction Pump is indicated for all situations where chest drains are applied - especially for thoracic drainage in the pleural and mediastinal cavity in situations such as pneumothorax, after cardiac or thoracic surgery (post-operative), thorax injury, pleural effusion, pleural empyema or other related conditions. The Medela® THOPAZ Suction Pump is intended for use on patients in appropriate care settings.
Product codes
BTA
Device Description
Medela® THOPAZ Trade Name: Secretion & Surgical Aspirator Common Name: Powered Suction Pump
The Medela® THOPAZ Suction Pump is equipped with the identical technology like other marketed devices. These technological features do not affect safety and effectiveness of the device or the application (pleural and mediastinal drainage).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pleural and mediastinal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patients in appropriate care settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medela® THOPAZ, K080212
Reference Device(s)
Oasis™ Chest Drain, K043140
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the word "medela" in a bold, sans-serif font. To the right of the word is a stylized graphic of three leaves arranged in a triangular shape. The leaves are outlined in black and have a slightly textured appearance.
Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerl Annlicant Markus Bütler, Tel +41 (41) 769 51 51; Fax +41 (41) 769 51 00 Contact Person markus.buetler@medela.ch Traditional 510(k) Submission for Medela® THOPAZ Suction Pump
MAR 1 5 2013
Section 5 - 510(k) Summary
This 510(k) summary for the Medela® THOPAZ Suction Pump meets the requirements of 21 CFR 807.92.
Sponsor's Name, Address and Contact Person 1.
Sponsor: Medela AG Medical Equipment Laettichstrasse 4b 6341 Baar Switzerland +41 41 769 5151 Ph: Fax: +41 41 769 5100 Contact Person Markus Bütler VP QM and RA
Date Summary Prepared: January 18, 2013
Name of Device 2.
Medela® THOPAZ Trade Name: Secretion & Surgical Aspirator
Common Name: Powered Suction Pump
Classification Name: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) Classified Class II, per 21 CFR 878.4780
Product Code: BTA
Name of the predicate Device(s) 3.
• Medela® THOPAZ, K080212
· Oasis™ Chest Drain, K043140
1
Image /page/1/Picture/0 description: The image shows the word "medela" in a bold, sans-serif font. To the right of the word is a small graphic of three teardrop shapes arranged in a triangular pattern. The word and graphic are both in black and are set against a white background.
Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Applicant: Markus Bütler, Tel +41 (41) 769 51 51; Fax +41 (41) 769 51 00 Contact Person: markus.buetler@medela.ch Traditional 510(k) Submission for Medela® THOPAZ Suction Pump
The Medela® THOPAZ Suction Pump is equipped with the identical technology like other marketed devices. These technological features do not affect safety and effectiveness of the device or the application (pleural and mediastinal drainage).
7. Conclusion
There are no differences in performance or technology which significantly affect the safety and effectiveness of the device or the application (pleural and mediastinal drainage). All conclusions are made by the decision making process according to the recommendations in the "510(k) SE Decision Making Process" document.
The Medela® THOPAZ suction pump has the identical intended uses and, where applicable, the identical technological characteristics and performance data as the predicate devices.
Based upon the information presented in this submission, it is proven that the proposed Medela® THOPAZ powered suction pump is substantially equivalent, safe and effective for the intended use.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird with three stylized wing or feather shapes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medela AG % Mr. Markus Bütler Vice President, Quality Management and Regulatory Affairs Laettichstrasse 4b Baar, Zug Switzerland CH-6341
March 15, 2013
Re: K130210
Trade/Device Name: Medela® THOPAZ Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: BTA Dated: January 18, 2013 Received: January 29, 2013
Dear Mr. Bütler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Markus Bütler
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for.the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours, FOR
Peter.D.Rumm-S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) number (if known):n/a K130210
Device Name: Medela® THOPAZ
Indications for Use:
The Medela® THOPAZ Suction Pump is intended to be used for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. The Medela® THOPAZ Suction Pump is indicated for all situations where chest drains are applied - especially for thoracic drainage in the pleural and mediastinal cavity in situations such as pneumothorax, after cardiac or thoracic surgery (post-operative), thorax injury, pleural effusion, pleural empyema or other related conditions. The Medela® THOPAZ Suction Pump is intended for use on patients in appropriate care settings.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Long H. Chen -A
for MXM
(Division Sign-off) Division of Surgical Devices 510(k) Number K130210